search
Back to results

Virtual Occupational Therapy Application (VOTA)

Primary Purpose

Stroke, Hemiparesis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VOTA Therapy
Sponsored by
Barron Associates, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Hemiparesis, Activities of Daily Living, Virtual World, Occupational Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participant is a hemiparetic stroke survivor;
  • Time since last stroke at least 3 months;
  • Participant has antigravity strength at the elbow to at least 45 degrees of active flexion in the stroke affected arm;
  • Participant has antigravity shoulder strength to at least 30 degrees each in active flexion, abduction/adduction, and 15 degrees in active rotation from an upright seated position in the stroke affected arm;
  • Participant has visual acuity with corrective lenses of 20/50 or better;

Exclusion Criteria:

  • Existing participation in an upper extremity stroke rehabilitation program or planned participation during the study period;
  • Inability to understand and follow verbal directions;
  • Determination that participation would result in over exertion or significant discomfort or pain;
  • Determination that participation would result in significant agitation or elevated stress;
  • Withholding or withdrawal of consent by the participant;
  • Visual field deficit in either eye that impairs the ability to view the computer monitor;
  • Hemispatial neglect that impairs the ability process and perceive visual stimuli provided through the computer monitor;

Sites / Locations

  • UVA- HealthSouth Rehabilitation Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

VOTA Group

Arm Description

All enrolled subjects are in this arm. After pre-assessment subjects have an 8-week waiting period, after which a mid-assessment takes place. Subject then participate in VOTA therapy for 8 weeks, followed by a post-assessment . The pre-/mid-assessment difference is used to control for spontaneous recovery. The mid-/post-assessment difference is used to ascertain efficacy.

Outcomes

Primary Outcome Measures

Fugl-Meyer upper extremity assessment
Measure of upper extremity motor function

Secondary Outcome Measures

Wolf Motor Function Test
Measure of upper extremity motor function
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Cognitive assessment
Trail Making Test
Cognitive assessment

Full Information

First Posted
March 3, 2016
Last Updated
August 11, 2017
Sponsor
Barron Associates, Inc.
Collaborators
University of Virginia
search

1. Study Identification

Unique Protocol Identification Number
NCT02706912
Brief Title
Virtual Occupational Therapy Application
Acronym
VOTA
Official Title
Virtual Occupational Therapy Application
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barron Associates, Inc.
Collaborators
University of Virginia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Virtual Occupational Therapy Application (VOTA) combines low-cost human motion tracking, commercial game engine technology, and evidence-based Occupational Therapy (OT) practice in a computer-based virtual world in which stroke patients practice activities of daily living (ADLs). The protocol investigates the efficacy of VOTA therapy for Upper Extremity (UE) motor recovery and assesses system usability and user acceptance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiparesis
Keywords
Stroke, Hemiparesis, Activities of Daily Living, Virtual World, Occupational Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VOTA Group
Arm Type
Experimental
Arm Description
All enrolled subjects are in this arm. After pre-assessment subjects have an 8-week waiting period, after which a mid-assessment takes place. Subject then participate in VOTA therapy for 8 weeks, followed by a post-assessment . The pre-/mid-assessment difference is used to control for spontaneous recovery. The mid-/post-assessment difference is used to ascertain efficacy.
Intervention Type
Behavioral
Intervention Name(s)
VOTA Therapy
Intervention Description
During sessions of approximately one hour in duration, participants practice performing virtual activities of daily living (ADLs) using the VOTA system. During this practice, the participant's real-world motion is replicated by an avatar's motion in the virtual world. To complete the activities, participant's must perform a wide range of functional arm movements while interacting with virtual objects. Individuals are asked to perform three such one-hour virtual ADL practice sessions per week over a participation period of approximately eight weeks.
Primary Outcome Measure Information:
Title
Fugl-Meyer upper extremity assessment
Description
Measure of upper extremity motor function
Time Frame
Pre-assessment and Post-assessment (8 weeks)
Secondary Outcome Measure Information:
Title
Wolf Motor Function Test
Description
Measure of upper extremity motor function
Time Frame
Pre-assessment and Post-assessment (8 weeks)
Title
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Description
Cognitive assessment
Time Frame
Pre-assessment and Post-assessment (8 weeks)
Title
Trail Making Test
Description
Cognitive assessment
Time Frame
Pre-assessment and Post-assessment (8 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant is a hemiparetic stroke survivor; Time since last stroke at least 3 months; Participant has antigravity strength at the elbow to at least 45 degrees of active flexion in the stroke affected arm; Participant has antigravity shoulder strength to at least 30 degrees each in active flexion, abduction/adduction, and 15 degrees in active rotation from an upright seated position in the stroke affected arm; Participant has visual acuity with corrective lenses of 20/50 or better; Exclusion Criteria: Existing participation in an upper extremity stroke rehabilitation program or planned participation during the study period; Inability to understand and follow verbal directions; Determination that participation would result in over exertion or significant discomfort or pain; Determination that participation would result in significant agitation or elevated stress; Withholding or withdrawal of consent by the participant; Visual field deficit in either eye that impairs the ability to view the computer monitor; Hemispatial neglect that impairs the ability process and perceive visual stimuli provided through the computer monitor;
Facility Information:
Facility Name
UVA- HealthSouth Rehabilitation Hospital
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22901
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Virtual Occupational Therapy Application

We'll reach out to this number within 24 hrs